US Government Establishes Fill–Finish Network

Oct 04, 2013

By PharmTech Editors

To boost the nation’s ability to manufacture influenza vaccine quickly in a pandemic, the US Department of Health and Human Services (HHS) has established a fill–finish manufacturing network, which will cover the final steps in the vaccine-manufacturing process. Led by HHS, the network supplements the capacity that influenza vaccine manufacturers currently have, potentially increasing national capacity to produce influenza vaccine by 20%.

The Biomedical Advanced Research and Development Authority (BARDA), in HHS’ Office of the Assistant Secretary for Preparedness and Response, awarded contracts to four US companies that will make up the network. The contracts, totaling approximately $39.8 million, were awarded to Cook Pharmica of Bloomington, Indiana, JHP Pharmaceuticals of Parsippany, New Jersey, DSM Pharmaceuticals of Greenville, North Carolina, and Nanotherapeutics of Alachua, Florida.

The new network responds to a recommendation proposed by the Public Health Medical Countermeasure Enterprise Review (2010) to create a network of existing, prequalified facilities that could fill–finish vaccine for manufacturers in a public health emergency. As a network, these companies will collaborate with the three HHS Centers for Innovation in Advanced Development and Manufacturing, established in 2012, and with domestic influenza vaccine manufacturers. In addition the network will provide its services to HHS for production of clinical investigational lots of medical countermeasures that are in development.

Each company in the network will partner with a pandemic influenza vaccine manufacturer to transfer the fill–finish technology into its existing facilities to provide surge capacity for pandemic response. The expanded fill–finish manufacturing network also could provide these core services for manufacturers of drugs and vaccines intended to protect public health against chemical, biological, radiological, and nuclear threats, according to HHS. The network builds on BARDA’s public–private partnership model to provide a coordinated national medical countermeasure manufacturing infrastructure.